Rubraca

RSS

rucaparib

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Rubraca and why it is authorised in the EU

Rubraca is a cancer medicine for adults with high-grade cancers of the ovary, fallopian tubes (the tubes connecting ovaries to the uterus) and the peritoneum (the membrane lining the abdomen).

Patients taking this medicine must have mutations (defects) in genes known as BRCA and their cancer must respond to treatment with platinum-based medicines (another type of cancer medicine).

Rubraca is for patients who have already had at least two treatments with platinum-based medicines but can no longer have these medicines.

Rubraca contains the active substance rucaparib.

Ovarian cancer is rare, and Rubraca was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 10 October 2012.

This EPAR was last updated on 31/05/2018

Authorisation details

Product details
Name
Rubraca
Agency product number
EMEA/H/C/004272
Active substance
rucaparib camsylate
International non-proprietary name (INN) or common name
rucaparib
Therapeutic area (MeSH)
Ovarian Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XX
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Clovis Oncology UK Limited
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
24/05/2018
Contact address
Sheraton House
Castle Park
Cambridge CB3 0AX
United Kingdom

Product information

24/05/2018 Rubraca - EMEA/H/C/004272 - -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTINEOPLASTIC AGENTS

Therapeutic indication

Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.

Assessment history

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